Help with DCB 0129 compliance
What is DCB 0129?
DCB 0129 is a mandatory UK risk management standard and all suppliers of health IT systems must comply (see NHS England page). The majority of NHS organisations will insist that suppliers provide evidence of compliance before a health IT system is implemented. The work must be conducted by a clinician with a current professional registration and experience in the application of risk management to clinical domains and culminates in the issuing of a Hazard Log and Clinical Safety Case Report. Without help, it can be a resource-intensive project. It’s common for a DCB 0129 document set to total more than 30,000 words.
See our Quick Guide to DCB 0129 and DCB 0160
Hazard Log and Safety Case Development
Safehand will work with you side-by-side to examine your product and create the necessary DCB 0129 documentation. Our staff have created hundreds of Hazard Logs and Safety Cases over the last nineteen years. Such experience brings with it a deep understanding of the risk management techniques and processes which work in a healthcare setting.
Beginning a Hazard Log and Safety Case with a blank sheet of paper and minimal experience is an arduous and unenviable task. Safehand employs tried and tested methods and templates which map accurately to the requirements of the DCB 0129 standard. These valuable assets greatly accelerate the process whilst adding rigour and repeatability.
Safehand’s iterative approach to Hazard Log and Safety Case development means that the materials we create are not bureaucratic artefacts to tick a box and be filed away. Instead, they are tools which our customer can harness to optimise system design, drive validation and prioritise issue resolution.
How can we help?
Contact us to discuss how we can help you to build the collateral you need to manage clinical safety and comply with the DCB 0129 standard.
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